Stratum 1- Regimen CS for Ototoxicity

Q: What are the criteria for enlistment in this clinical experimentation?

To partake in this clinical trial, prospective patients must have ototoxicity from a drug-based cause and be between 1 month and 39 years old. Currently, 33 people are being recruited for the study.

Q: Are there any remaining vacancies for those interested in participating within this trial?

Affirmative. According to clinicaltrials.gov, this <a href="https://www.withpower.com/clinical-trials/experimental">experimental</a> research is currently searching for volunteers; it was first published on March 1st 2023 and most recently updated on the 2nd of that same month. The team seeks 33 participants from a single facility.

Q: How extensive is the participant pool of this research experiment?

Affirmative. The clinicaltrials.gov website exhibits that this trial, which was initially listed on March 1st 2023, is actively recruiting participants. 33 individuals are needed to participate from a single medical site.

Q: Is the age requirement for this trial flexible enough to accept participants aged 70 and over?

The requirements to become a participant in this research include being between 1 Month and 39 years old. 32 trials are available for minors, while 15 focus on elderly individuals.

Cincinnati Children's Hospital Medical Center, Cincinnati, OH

Sodium ThiosulfatePhase < 1RecruitingLed by James Geller, MDResearch Sponsored by Children's Hospital Medical Center, Cincinnati

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Organ Function Requirements:

- Stratum 2B: CSS: Relapsed/refractory Wilms tumor, Germ Cell Tumor, or Neuroblastoma

Must not have

Be older than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Upthrough study completion up to 5 years

Awards & highlights

No Placebo-Only Group

Study Summary

This trial will test a drug (Sodium Thiosulfate) to see if it can prevent hearing loss from chemotherapy. #medicaltrial

Eligible Conditions

Ototoxicity

Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below

Select...

Can you please provide more specific details about the organ function requirements?

Select...

You have Wilms tumor, Germ Cell Tumor, or Neuroblastoma that has come back or is not responding to treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion up to 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Prevention of hearing loss

Secondary outcome measures

Maximum Plasma Concentration [Cmax]

Number of Participants with Treatment-Related Adverse Events

Prevention of hearing loss and tumor reduction

+2 more

Side effects data

From 2020 Phase 2 trial • 21 Patients • NCT02092298

Lung Injury

Blood Clot

Kidney dysfunction

Arrythmia

100%

80%

60%

40%

20%

Study treatment Arm

Hyperthermic Intraperitoneal Chemotherapy (HIPEC)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Group I: Stratum 2B- Regimen CSSExperimental Treatment1 Intervention

Wilms tumor, GCT, Neuroblastoma

Group II: Stratum 2A- Regimen CSSExperimental Treatment1 Intervention

Cisplatin resistant or progressed on cisplatin after initial response (when given at first diagnosis)

Group III: Stratum 1- Regimen CSExperimental Treatment1 Intervention

Cisplatin sensitive/no progression on cisplatin (when given at first diagnosis)

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Sodium Thiosulfate

2014

Completed Phase 2

~70

0 / 2Eligibility criteria met

Find a site

Who is running the clinical trial?

Children's Hospital Medical Center, CincinnatiLead Sponsor

786 Previous Clinical Trials

5,524,034 Total Patients Enrolled

James Geller, MDPrincipal Investigator

Children's Hospital Medical Center, Cincinnati

5 Previous Clinical Trials

1,087 Total Patients Enrolled

Media Library

Stratum 1- Regimen CS Clinical Trial Eligibility Overview. Trial Name: NCT05756660 — Phase < 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the criteria for enlistment in this clinical experimentation?

"To partake in this clinical trial, prospective patients must have ototoxicity from a drug-based cause and be between 1 month and 39 years old. Currently, 33 people are being recruited for the study."

Answered by AI

Are there any remaining vacancies for those interested in participating within this trial?

"Affirmative. According to clinicaltrials.gov, this experimental research is currently searching for volunteers; it was first published on March 1st 2023 and most recently updated on the 2nd of that same month. The team seeks 33 participants from a single facility."

Answered by AI

How extensive is the participant pool of this research experiment?

"Affirmative. The clinicaltrials.gov website exhibits that this trial, which was initially listed on March 1st 2023, is actively recruiting participants. 33 individuals are needed to participate from a single medical site."

Answered by AI

Is the age requirement for this trial flexible enough to accept participants aged 70 and over?

"The requirements to become a participant in this research include being between 1 Month and 39 years old. 32 trials are available for minors, while 15 focus on elderly individuals."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Sodium Thiosulfate Otoprotection During Salvage Cisplatin Therapy

2023. "Sodium Thiosulfate Otoprotection During Salvage Cisplatin Therapy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05756660.